Investigating combination treatment in chronic kidney disease and hypertension
The BaxDuo-PACIFIC study investigates the efficacy and safety of baxdrostat in combination with dapagliflozin in people with chronic kidney disease and hypertension. Find information about the study design, eligibility criteria and participating centres.
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BaxDuo-PACIFIC: baxdrostat and dapagliflozin in chronic kidney disease
Study summary
BaxDuo-Pacific is a Phase III, multicentre, randomised, double-blind, placebo-controlled, event-driven trial evaluating the efficacy and safety of baxdrostat plus dapagliflozin compared with dapagliflozin alone in patients with CKD and hypertension. Approximately 5,000 participants will be enrolled.
Which patients may be eligible?
Key inclusion criteria
- Participants of any sex or gender must be at least 18 years of age at the time of signing the informed consent.
- Participants meeting either (a) or (b): (a) eGFR 30–59 mL/min/1.73 m² (local or central laboratory value) AND at least one of the following: UACR ≥ 30 mg/g (3.39 mg/mmol) and less than 500 mg/g (56.5 mg/mmol) (central laboratory value only), OR UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), OR UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only); OR (b) eGFR 60–75 mL/min/1.73 m² (local or central laboratory value) AND at least one of the following: UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), OR UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only).
- Participants with a history of hypertension (HTN) and a systolic blood pressure (SBP) ≥ 130 mmHg (the most recent value within 4 weeks before screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.
- Use of a stable and maximally tolerated dose of an ACE inhibitor (ACEi) or an angiotensin II receptor blocker (ARB), but not both, for at least 4 weeks before the Screening Visit.
- Participants meeting either (a) or (b): (a) serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m² (local or central laboratory value); OR (b) serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR is less than 45 mL/min/1.73 m² (local or central laboratory value).
Key exclusion criteria
- Conditions that may interfere with study participation or interpretation of results
- Clinically significant uncontrolled disease
- Use of prohibited concomitant therapies
- Other protocol-defined exclusions affecting safety or efficacy assessment
Eligibility is assessed exclusively by the treating physician or study team.
About this study
Study aim
To evaluate whether baxdrostat in combination with dapagliflozin reduces the risk of kidney disease progression, heart failure events, or cardiovascular death in patients with chronic kidney disease (CKD) and hypertension.
Intervention / treatment
Baxdrostat/dapagliflozin
Study design
A Phase III, randomised, double-blind, placebo-controlled, event-driven study.
Trial duration per participant
37 months
Participating centres
UMCG
Relevant links
Contact NEFRO-NL
How can we help you?
Would you like to learn more about NEFRO-NL, our research network or our services? Our project managers are happy to help. Contact us at info@nefro-nl.nl.
Antina de Boer
Project Manager
